RecruitingNAINTERVENTIONAL

Ofloxacin Concentration-toxicity Relationship in the Elderly

This research is about an antibiotic called ofloxacin, which is often used to treat bone and joint infections, especially those caused by certain bacteria. We know that older people can react differently to medicines; sometimes the drug might not work as well, or it might cause more side effects. This study aims to understand if there's a link between how much ofloxacin is in a person's blood and if they experience side effects. We hope to find a level of the drug that might be too high, so doctors can give safer and more effective treatment. This is important for ensuring older patients get the best care without unnecessary risks.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

110

Start

02 Jun 2020

Estimated completion

01 Aug 2026

Ofloxacin Bone and Joint Infection Therapeutic Drug Monitoring Adverse Drug Reactions

What is this study about?

This study is investigating an antibiotic called ofloxacin, which is a common medicine used to treat serious bone and joint infections. For many years, it has been a reliable choice for infections caused by certain types of bacteria.

However, when older people take this medicine, we've noticed that the drug can behave differently in their bodies compared to younger people. This means it might be less effective or, importantly, cause more unwanted side effects. Doctors don't currently have a clear guide about what level of this drug in the blood might start causing problems.

The main goal of this research is to see if there's a direct connection between the amount of ofloxacin found in a person's blood after a few days of treatment and whether they experience any side effects. If we find this connection, we can then figure out a specific 'danger level' for the drug. This information would be really helpful for doctors to adjust dosages, making sure older patients get the right amount of medicine to fight their infection effectively without experiencing too many side effects. It's all about making treatments safer and more tailored for each patient.

Key takeaways

This study aims to make antibiotic treatment safer for older adults.
It focuses on an antibiotic called ofloxacin used for bone and joint infections.
Researchers want to find a link between drug levels in the blood and side effects.
The goal is to help doctors fine-tune medicine doses for older patients.
Participation involves giving a blood sample and answering questions about your health.

Who may be eligible?

This study is looking for volunteers who are 65 years old or older. You would need to be in the hospital in Amiens, France, for a bone or joint infection that isn't too complicated. You also need to be switching from drips to taking ofloxacin tablets as part of your treatment.

There are some reasons why you wouldn't be able to join. This includes if you don't want to take part, or if you have certain legal restrictions on making decisions for yourself. You also can't participate if you have any serious liver problems or any known medical reasons why you shouldn't take ofloxacin, such as a previous bad reaction to it.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 65 years old or older?
Are you in the hospital for a bone or joint infection?
Are you about to start taking ofloxacin tablets?
Do you feel comfortable taking part in a study?
Do you have any serious liver problems or previous bad reactions to ofloxacin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given ofloxacin as part of your usual treatment for your bone and joint infection. The study involves answering some short questions about how you are feeling and if you have noticed any side effects. This will likely happen around day 3 of your treatment. At the same time, a small blood sample will be taken to measure the level of ofloxacin in your system. This is done as part of routine care or at day 3. There are no extra tests or visits beyond what is already planned for your treatment. The total duration of your involvement in the study will be focused on the first few days of your ofloxacin treatment.

Potential risks and benefits

Taking part might give us valuable information that could help improve how ofloxacin is used for older patients in the future, potentially leading to safer and more effective treatment for many people. The main risk involves having a blood sample taken, which can sometimes cause a small bruise or discomfort. You also have the right to change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU Amiens
Verified postcode
Amiens, France· Recruiting

Common questions

What is ofloxacin?

Ofloxacin is a strong antibiotic medicine used to treat serious bacterial infections, especially in bones and joints.

Why is this study important for older people?

Older people can react differently to medicines, so this study helps doctors understand how to give ofloxacin safely and effectively to them, reducing side effects.

Will I get extra medicine or different treatment?

No, you will receive the same ofloxacin treatment that your doctors would normally prescribe for your infection.

What is a 'side effect' in this study?

A side effect is any unwanted reaction or problem that might happen because of taking a medicine.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any point, and it won't affect the medical care you receive.

How to find out more

Youssef BENNIS, MD

bennis.youssef@chu-amiens.fr (33)32208700 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.